(rayse'' ep i nef' rin hye'' droe klor' ide).
» Racepinephrine Hydrochloride is a racemic mixture of the hydrochlorides of the enantiomorphs of epinephrine. It contains not less than 97.0 percent and not more than 102.0 percent of C9H13NO3·HCl, calculated on the anhydrous basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
A: Ultraviolet Absorption 197U
Solution: 50 µg per mL. [noteUse USP Epinephrine Bitartrate RS in the preparation of the Standard solution. ]
B: A solution (1 in 100) meets the requirements of the tests for Chloride 191.
Specific rotation 781S: between 1 and +1.
Test solution: 10 mg per mL, in 0.12 N hydrochloric acid.
Water, Method I 921: not more than 0.5%.
Residue on ignition 281: not more than 0.5%.
Other requirements It meets the requirements for Limit of adrenalone and Limit of norepinephrine under Racepinephrine.
Mobile phase Prepare a filtered and degassed solution of 0.17 N acetic acid. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve an accurately weighed quantity of USP Epinephrine Bitartrate RS in Mobile phase to obtain a solution having a known concentration of about 150 µg per mL.
Assay preparation Transfer about 25 mg of Racepinephrine Hydrochloride, accurately weighed, to a 100-mL volumetric flask. Dissolve in and dilute with Mobile phase to volume, and mix. Transfer 4.0 mL of this solution to a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a solution containing about 100 µg per mL.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 278-nm detector and a 4.6-mm × 15-cm column that contains packing L1. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C9H13NO3·HCl in the portion of Racepinephrine Hydrochloride taken by the formula:
0.25C(219.67 / 333.30)(rU / rS)in which C is the concentration, in µg per mL, of USP Epinephrine Bitartrate RS in the Standard preparation: 219.67 and 333.30 are the molecular weights of racepinephrine hydrochloride and epinephrine bitartrate, respectively; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4512Pharmacopeial Forum: Volume No. 32(6) Page 1752